EP3777707B1 - Suturing device - Google Patents

Suturing device Download PDF

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Publication number
EP3777707B1
EP3777707B1 EP19796242.6A EP19796242A EP3777707B1 EP 3777707 B1 EP3777707 B1 EP 3777707B1 EP 19796242 A EP19796242 A EP 19796242A EP 3777707 B1 EP3777707 B1 EP 3777707B1
Authority
EP
European Patent Office
Prior art keywords
needle
needles
suture
holding member
casing
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Active
Application number
EP19796242.6A
Other languages
German (de)
English (en)
French (fr)
Other versions
EP3777707A4 (en
EP3777707A1 (en
Inventor
Naokatsu Osawa
Ryuta Iijima
Masashi ICHIHASHI
Kohei Terada
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Brother Industries Ltd
Original Assignee
Brother Industries Ltd
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Filing date
Publication date
Application filed by Brother Industries Ltd filed Critical Brother Industries Ltd
Publication of EP3777707A1 publication Critical patent/EP3777707A1/en
Publication of EP3777707A4 publication Critical patent/EP3777707A4/en
Application granted granted Critical
Publication of EP3777707B1 publication Critical patent/EP3777707B1/en
Active legal-status Critical Current
Anticipated expiration legal-status Critical

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Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/04Surgical instruments, devices or methods, e.g. tourniquets for suturing wounds; Holders or packages for needles or suture materials
    • A61B17/0482Needle or suture guides
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/04Surgical instruments, devices or methods, e.g. tourniquets for suturing wounds; Holders or packages for needles or suture materials
    • A61B17/0469Suturing instruments for use in minimally invasive surgery, e.g. endoscopic surgery
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/04Surgical instruments, devices or methods, e.g. tourniquets for suturing wounds; Holders or packages for needles or suture materials
    • A61B17/06Needles ; Sutures; Needle-suture combinations; Holders or packages for needles or suture materials
    • A61B17/06061Holders for needles or sutures, e.g. racks, stands
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/04Surgical instruments, devices or methods, e.g. tourniquets for suturing wounds; Holders or packages for needles or suture materials
    • A61B17/0485Devices or means, e.g. loops, for capturing the suture thread and threading it through an opening of a suturing instrument or needle eyelet
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B2017/00535Surgical instruments, devices or methods, e.g. tourniquets pneumatically or hydraulically operated
    • A61B2017/00557Surgical instruments, devices or methods, e.g. tourniquets pneumatically or hydraulically operated inflatable
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/04Surgical instruments, devices or methods, e.g. tourniquets for suturing wounds; Holders or packages for needles or suture materials
    • A61B17/0469Suturing instruments for use in minimally invasive surgery, e.g. endoscopic surgery
    • A61B2017/0472Multiple-needled, e.g. double-needled, instruments
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/04Surgical instruments, devices or methods, e.g. tourniquets for suturing wounds; Holders or packages for needles or suture materials
    • A61B17/0469Suturing instruments for use in minimally invasive surgery, e.g. endoscopic surgery
    • A61B2017/0474Knot pushers
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/04Surgical instruments, devices or methods, e.g. tourniquets for suturing wounds; Holders or packages for needles or suture materials
    • A61B17/06Needles ; Sutures; Needle-suture combinations; Holders or packages for needles or suture materials
    • A61B17/06004Means for attaching suture to needle
    • A61B2017/06042Means for attaching suture to needle located close to needle tip

Definitions

  • aspects disclosed herein relate to a suturing device that stitches a relatively wide area in edges of a cut at once using a suture without using metal staples.
  • a known suturing device is used for closing edges of a cut with staples in surgical operations.
  • Such a suturing device sutures a relatively wide area in edges of a cut (e.g., edges of a cut entirely) at once.
  • JP S60 85736 A discloses a hysterectomium which comprises beside of clamping jaws on one side of the clamping jaws a cutting blade for cutting of tissue and on the other side of the clamping jaws a stitching device.
  • JP 2011 147770 A discloses a suturing system for receiving and retaining a suture including at least one needle having a tapered end, and a groove traversing the tapered end, wherein the groove receives a part of the suture and removably retains the suture.
  • At least one retainer has a body that defines an aperture. The shape of the aperture is defined by a central passageway, and a pair of diametrically opposed slots extending radially outward from the central passageway. The central passageway is sized to allow passage of the needle passing therethrough. Each slot defines a tortured path section that permits passage of the suture in a first direction and inhibits passage of the suture in a second direction.
  • the staples used for suturing may be made of metal, and in some cases, permanently remain inside a patient's body. In such a case, nevertheless, one or more of the staples may come off in the patient's body and this may cause pain to the patient.
  • a fastening strength to secure a closure might not be adjustable depending on types or conditions of portions to be sutured.
  • staple suturing may be unsuitable for a relatively soft portion to be sutured.
  • suturing using forceps with a needle and a suture threaded through the needle may have flexibility in adjustment.
  • a range to be sutured may be adjustable by changing the number of stitches to be placed and a fastening strength to secure a closure may be adjustable depending on types or conditions of portions to be sutured.
  • stiches may be placed, one by one, to close a cut.
  • Such suturing may be a skilled technique, and in a case where a cut to be sutured is wide, it may take a relatively long time for suturing edges of a cut.
  • aspects of the disclosure provide a suturing device that may enable a user with less experience to stitch edges of a wide cut with a suture for a relatively short time.
  • a suturing device 10 includes a couple of casings including a first casing 12 and a second casing 14 at its distal end portion.
  • the first casing 12 and the second casing 14 each have an elongated box shape.
  • a known open/close mechanism is equipped with the first casing 12 and the second casing 14.
  • the open/close mechanism is configured to open and close the suturing device 10 to move the first casing 12 and the second casing 14 relatively away from and toward each other.
  • the open/close mechanism is disposed at a distal end of a tubular member 16 having an outside diameter of approximately 5 to 10 mm.
  • the tubular member 16 is inserted into an abdominal cavity of a living body during surgery.
  • the open/close mechanism includes a jaw mount, a cylindrical drive shaft, and a cam block. While fixedly supporting the first casing 12, the jaw mount supports the second casing 14 to be movable toward or away from the first casing 12.
  • the drive shaft has a diameter slightly smaller than the tubular member 16.
  • the drive shaft is slidably engaged in the tubular member 16 and is movable along a longitudinal axis of the tubular member 16.
  • the cam block is disposed at a distal end of the drive shaft.
  • the second casing 14 includes a cam arm 18 at its proximal end. In response to the drive shaft being operated to move toward the second casing 14, the cam arm 18 is pressed against the cam block, and thus, the second casing 14 moves toward the first casing 12.
  • the cam arm 18 In response to the drive shaft being operated to move away from the second casing 14, the cam arm 18 is separated from the cam block, and thus, the second casing 14 moves away from the first casing 12 by an urging force of a return spring disposed in the jaw mount.
  • the first casing 12 and the second casing 14 may function as a first holding member and a second holding member, respectively, that may hold therebetween edges of a cut T, for example, a tissue of a living body.
  • the first casing 12 and the second casing 14 may be coupled to each other at their proximal ends by a certain pin, thereby being pivotable about the pin to be relatively moved away from and toward each other.
  • the first casing 12 includes a pair of side walls 20 and 22 and a bottom wall 24 that are integral with each other.
  • the side walls 20 and 22 are elongated walls extending parallel to each other.
  • Each of the side walls 20 and 22 has one end and the other end opposite to each other.
  • the one ends of the respective side walls 20 and 22 face the second casing 14 and are closer to the second casing 14 than the other ends of the respective side walls 20 and 22 are to the second casing 14.
  • the bottom wall 24 is an elongated wall and connects between the other ends of the side walls 20 and 22.
  • the first casing 12 accommodates needle stands 28 in its distal end portion in a longitudinal axis thereof. Each needle stand 28 holds a needle 26.
  • the first casing 12 includes a first casing body 30, a plurality of holes 32 (only one of which is illustrated in FIG. 5 ), and a pressing plate 34.
  • the first casing body 30 has a U-shape in cross section and an open end facing the second casing 14.
  • the pressing plate 34 has the holes 32 penetrating therethrough to allow a corresponding needle 26 to pass through the pressing plate 34.
  • the pressing plate 34 is disposed to close a distal end portion of the open end of the first casing body 30. As illustrated in FIG.
  • the first casing 12 further includes a first needle pusher 38 and a second needle pusher 40.
  • the first needle pusher 38 and the second needle pusher 40 are accommodated in a proximal end portion of the first casing body 30 in the longitudinal axis of the first casing 12.
  • the first needle pusher 38 and the second needle pusher 40 are configured to move the needles 26 up and down.
  • the first needle pusher 38 is disposed above the bottom wall 24 and the second needle pusher 40 is disposed above the first needle pusher 38 in the first casing body 30. In such a state, the first needle pusher 38 and the second needle pusher 40 are slidable along the longitudinal axis of the first casing 12.
  • the first needle pusher 38 and the second needle pusher 40 are an example of a pusher.
  • the first needle pusher 38 and the second needle pusher 40 are connected to respective operating rods disposed in the tubular member 16.
  • Each of the first needle pusher 38 and the second needle pusher 40 is configured to move between a distal-end side position and a proximal-end side position in the first casing body 30 by operation of a corresponding operating rod.
  • the first needle pusher 38 and the second needle pusher 40 may be elongated members each having a rectangular shape in cross section.
  • the first needle pusher 38 and the second needle pusher 40 each have a width slightly narrower than a gap between the side walls 20 and 22 of the first casing body 30.
  • the first needle pusher 38 and the second needle pusher 40 are guided independently of each other by the side walls 20 and 22 along the longitudinal axis of the first casing 12 when being operated by the respective operating rods.
  • the first needle pusher 38 includes a first inclined surface 38a and a first positioning surface 38b.
  • the first needle pusher 38 has the first inclined surface 38a at its leading end.
  • the first inclined surface 38a is configured to engage bottom surfaces 28a of the needle stands 28 one after another to push up the needle stands 28 from the bottom wall 24 (e.g., move the needle stands 28 toward the second casing 14).
  • the first positioning surface 38b may be a flat surface contiguous from the first inclined surface 38a, and is configured to position the respective needle stands 28 at a first height. The first height is constant and predetermined.
  • the second needle pusher 40 is disposed on the first needle pusher 38.
  • the second needle pusher 40 includes a second inclined surface 40a and a second positioning surface 40b.
  • the second needle pusher 40 has the second inclined surface 40a at its leading end.
  • the second inclined surface 40a is configured to engage the bottom surfaces 28a of the needle stands 28 that have been raised by the first needle pusher 38, one after another, to further push up the needle stands 28 (e.g., further move the needle stands 28 toward the second casing 14) from the first height.
  • the second positioning surface 40b may be a flat surface contiguous from the second inclined surface 40a, and is configured to position the respective needle stands 28 at a second height.
  • the second height is constant.
  • the first height corresponds to a first protrusion amount h1 (refer to FIGS. 13 and 37 ).
  • the first protrusion amount h1 refers to a protrusion amount of a needle 26 from the pressing plate 34.
  • the second height corresponds to a second protrusion amount h2 (refer to FIGS. 12 and 36 ).
  • the second protrusion amount h2 refers to another protrusion amount of a needle 26 from the pressing plate 34.
  • the needle stands 28, the first needle pusher 38 and the second needle pusher 40 may function as a needle moving mechanism 41.
  • the needle moving mechanism 41 is configured to move the respective needles 26 up and down.
  • the second needle pusher 40 is disposed on the first needle pusher 38. Nevertheless, in other embodiments, for example, when viewed from a side facing into the page in FIG. 2 , the second needle pusher 40 may be disposed behind or in front of the first needle pusher 38.
  • the first needle pusher 38 and the second needle pusher 40 may be plate-like members having respective different heights. That is, the first needle pusher 38 may have any configuration as long as being capable of pushing up the needle stands 28 to the first height, and the second needle pusher 40 may also have any configuration as long as being capable of pushing up the needle stands 28 to the second height.
  • the second casing 14 includes a second casing body 48 and a cover plate 50.
  • the second casing body 48 includes a pair of side walls 42 and 44 and a bottom wall 46 that are integral with each other.
  • the side walls 42 and 44 are elongated walls extending parallel to each other.
  • Each of the side walls 42 and 44 has one end and the other end opposite to each other.
  • the other ends of the respective side walls 42 and 44 face the first casing 12 and closer to the first casing 12 than the one ends of the respective side walls 42 and 44 are to the first casing 12.
  • the bottom wall 46 is an elongated wall and connects between the other ends of the side walls 42 and 44.
  • the second casing body 48 has a U-shape in cross section and an open end facing a side opposite to the first casing 12.
  • the cover plate 50 partially covers the open end in a proximal end portion of the second casing body 48.
  • the bottom wall 46 of the second casing body 48 faces the pressing plate 34 that covers the open end in the distal end portion of the first casing body 30.
  • the bottom wall 46 also functions as a pressing plate for sandwiching edges of a cut T in cooperation with the pressing plate 34.
  • the bottom wall 46 of the second casing body 48 has a slot 52 having a shape corresponding to a shape of the holes 32 that are connected to each other in the pressing plate 34.
  • the slot 52 allows all of the needles 26 to pass through the bottom wall 46.
  • the second casing 14 further includes a friction plate 54 on a particular surface of the bottom wall 46.
  • the particular surface of the bottom wall 46 faces the pressing plate 34 of the first casing 12.
  • the friction plate 54 may be made of, for example, material having a relatively high friction coefficient such as silicone rubber or may have a surface having a relatively high friction coefficient (e.g., a surface having microscopic asperities) for applying friction to a suture L hooked on a tip portion 26d of each needle 26.
  • the friction plate 54 is adhered to the bottom wall 46. As illustrated in FIG. 10 , the friction plate 54 has friction holes 56a and slots 56.
  • the friction holes 56a are positioned in such manner to allow the respective corresponding needles 26 to pass therethrough.
  • each of the friction holes 56a slidably contacts particular surfaces of the needle 26.
  • the particular surfaces of the needle 26 may be particular portions of a circumferential wall 26e of the needle 26 and face the side walls 20 and 22, respectively.
  • Each of the slots 56 is disposed between adjacent friction hole 56a and connects between the adjacent friction holes 56a.
  • Each of the friction holes 56a has concave surfaces each having a curvature radius as the same as a radius of a needle 26. This may enable each of the friction holes 56a to slidably contact the particular surfaces of the needles 26.
  • the second casing 14 further includes a suture hook 60 connected to an operating rod disposed in the tubular member 16.
  • the suture hook 60 is configured to, in a state where the suturing device 10 is closed so that first casing 12 and the second casing 14 are located close to each other, move between a distal-end side position and a proximal-end position in the second casing body 48 along a needle arrangement direction in which the needles 26 are aligned.
  • the suture hook 60 has the same or similar configuration to a latch needle specified in, for example, Japanese Industrial Standard: JIS L 0202.
  • the suture hook 60 includes a hook 62 at its distal end.
  • the hook 62 may be a curved end of the suture hook 60 for catching a suture L.
  • the suture hook 60 further includes a latch 63 (refer to FIG. 15 ), a butt 64, and a shank 65.
  • the latch 63 is configured to pivot to selectively open and close a mouth of the hook 62.
  • the butt 64 is disposed at a middle portion of the suture hook 60.
  • the shank 65 is disposed at a proximal end of the suture hook 60.
  • the side wall 42 of the second casing body 48 includes a suture hook guide 42a.
  • the suture hook guide 42a is configured to, in a case where the suture hook 60 is moved forward (e.g., toward the distal end of the second casing 14), guide the butt 64 of the suture hook 60 at a particular rotation angle about an axis of the suture hook 60. More specifically, for example, when the butt 64 is at the particular rotation angle, the hook 62 has a horizontal loop. With such a configuration, the suture hook 60 may move forward (e.g., toward the distal end of the second casing 14) while the hook 62 and butt 64 are each in a horizontal state where the hook 62 has a horizontal loop and the butt 64 extends parallel to the bottom wall 46.
  • the suture hook 60 In response to the hook 62 having passed the needle 26 that is disposed closest to the distal end of the second casing 14 (hereinafter, also referred to as a frontmost needle 26) among the needles 26, the suture hook 60 is rotated to the right about 90 degrees. This may enable the hook 62 to surely catch a suture L hooked on the needle 26. In a case where the suture hook 60 is moved backward (e.g., toward the proximal end of the second casing 14), the butt 64 is not guided by the suture hook guide 42a and the butt 64 extends perpendicular to the bottom wall 46 and the hook 62 has a vertical loop. Nevertheless, the suture hook 60 might not necessarily be configured to be rotated.
  • FIG. 1 illustrates the butt 64 in both cases where the suture hook 60 is located at the distal-end side position and where the suture hook 60 is located at the proximal-end side position.
  • the second casing 14 further includes a knot forming jig 66 at the proximal end portion in the second casing body 48.
  • the knot forming jig 66 is elongated and connected to an operating rod disposed in the tubular member 16.
  • the knot forming jig 66 also serves as a jig (e.g., a knot pusher) that pushes a knot to tighten and secure the knot.
  • the knot forming jig 66 is disposed next to the suture hook 60 in a width direction of the second casing 14 and configured to reciprocate along the longitudinal axis of the second casing 14.
  • the knot is tightened and secured by the knot pusher (e.g., the knot forming jig 66), thereby stably maintaining stiches placed in edges of a cut T.
  • the knot forming jig 66 includes a tapered portion 66a tarped toward its distal end.
  • the knot forming jig 66 has incomplete knots IM at a portion further to a proximal end of the knot forming jig 66 than the tapered portion 66a.
  • the incomplete knots IM are formed by a suture L wound around the knot forming jig 66.
  • a complete knot M (refer to FIGS. 24 and 25 ) is formed by drawing an end of a suture L extending from the suture bobbin 36 through a loop of the incomplete knots IM.
  • FIGS. 3 and 4 are a perspective view and a plan view, respectively, illustrating a state where the needle stands 28 are accommodated in the first casing body 30.
  • the pressing plate 34 and a suture cover 80 are omitted.
  • the needles 26 stand on the respective needle stands 28 to extend in a direction perpendicular to the respective bottom surfaces 28a of the needle stands 28.
  • the suture bobbin 36 is disposed at a particular portion further to the distal end of the first casing body 30 than the needle stand 28 on which the frontmost needle 26 stands.
  • the suture bobbin 36 is rotatable in a state where a suitable rotational resistance is applied to the suture bobbin 36 such that a suture L can be drawn from the suture bobbin 36 under appropriate tension.
  • the needle stand 28 has a width slightly narrower than the gap between the side walls 20 and 22 of the first casing body 30. The position of the needle stand 28 in its width direction is fixed by the side walls 20 and 22.
  • the needle stand 28 includes a pair of guide protrusions 70.
  • the guide protrusions 70 protrude toward the side walls 20 and 22, respectively.
  • the side walls 20 and 22 each have guide grooves 72 in their surfaces facing each other. Among the guide grooves 72 of the side walls 20 and 22, guide grooves 72 facing each other are paired.
  • the guide grooves 72 extend in a direction in which the needle 26 extends, that is, in the direction perpendicular to the bottom wall 24.
  • Each pair of the guide grooves 72 is engaged with a corresponding pair of guide protrusions 70 so as to guide a corresponding needle stand 28 to move in the direction perpendicular to the bottom wall 24.
  • the pairs of guide grooves 72 are spaced from each other in the longitudinal axis of the first casing body 30.
  • the needles 26 are spaced from each other at constant intervals along the longitudinal axis of the first casing 12 and extend toward the second casing 14.
  • the plurality of pairs of guide protrusions 70 and the plurality of pairs of guide grooves 72 constitute a needle stand guide 74.
  • the needle stand 28 has an annular groove 28b that is coaxial with the needle 26.
  • the annular groove 28b is configured to receive one end of a coil spring 78.
  • the bottom surface 28a of the needle stand 28 includes an inclined surface 28c at one end portion that is closer to the proximal end of the first casing 12, that is, closer to the first needle pusher 38 and the second needle pusher 40.
  • the inclined surface 28c may slidably contact the first inclined surface 38a of the first needle pusher 38 and the second inclined surface 40a of the second needle pusher 40, thereby facilitating moving the needle stand 28.
  • the needles 26 might not necessarily be spaced apart from each other at constant intervals along the longitudinal axis of the first casing 12.
  • the needle 26 may be a metal tube made of stainless steel and have a diameter of 0.6 to 1.0 mm.
  • the needle 26 has a slit 26a in the circumferential wall 26e.
  • the slit 26a extends in an axial direction of the needle 26.
  • the needle 26 has the tip portion 26d that has a bevel cut.
  • the needle 26 has a bevel 26b such that a particular portion of the needle 26 having the slit 26a serves as an acute angled tip of the needle 26.
  • the slit 26a extends in parallel to the axis of the needle 26 along the axial direction of the needle 26 from a point to an opposite end of the needle 26.
  • the needle 26 has chamfered surfaces 26c at its tip end.
  • the slit 26a has a width slightly greater than an outside diameter of a suture L. Nevertheless, the slit 26a might not necessarily extend from an end (e.g., the point) to the other end in the axial direction of the needle 26 as long as the needle 26 can hold a suture L at its tip.
  • the slit 26a may have a length corresponding to a length of the bevel 26b of the needle 26 in the axial direction of the needle 26.
  • the first casing 12 accommodates coil springs 78.
  • Each coil spring 78 is disposed between an inner surface of the pressing plate 34 and an annular groove 28b of a corresponding needle stand 28 while a certain preload is applied to each coil spring 78.
  • the pressing plate 34 is fixed to the first casing body 30 to close the open end of the first casing body 30.
  • the needles 26 are retracted in the first casing 12 at all times, such a configuration may allow the needles 26 to protrude from the pressing plate 34 one after another in increasing order of distance from the proximal end of the first casing 12 in response to the first needle pusher 38 and the second needle pusher 40 moving forward toward the distal end of the first casing 12.
  • FIG. 8 illustrates a state where the needle stand 28 disposed closest to the proximal end of the first casing 12 among the needle stands 28 is pushed up by the first inclined surface 38a of the first needle pusher 38.
  • the needles 26 may be configured to be retracted below the pressing plate 34 by their own weights.
  • the coil springs 78 might not necessarily be provided.
  • an urging force applied to each needle stand 28 may be generated by another suitable configuration other than the coil spring.
  • FIG. 9 illustrates how a suture L hooked on the tips of the needles 26 slightly protruding relative to the pressing plate 34 prior to suturing of edges of a cut T is routed on the pressing plate 34.
  • the suture bobbin 36 has a suture L wound therearound.
  • the suture L extends from the suture bobbin 36 and is placed in the slit 26a of the needle 26 disposed at a certain position of the first casing body 30, for example, the frontmost needle 26.
  • the suture L further extends to the needle 26 next to the frontmost needle 26 in the needle arrangement direction to be placed in the slit 26a of the second frontmost needle 26.
  • the suture L has a certain loosened portion W between the needles 26.
  • the loosened portion W is routed to form a W shape so as not to get tangled.
  • the pressing plate 34 may further include small protrusions for guiding routing of the suture L to form certain loosened portions W between needles 26.
  • a loosened portion W has a length twice or more as long as the second protrusion amount h2 of a needle 26 relative to the pressing plate 34.
  • the suture L on the pressing plate 34 extending between the slits 26a of the needles 26 is covered with a suture cover 80 to reduce slippage of the loosened portions W in the suture L from the pressing plate 34.
  • the suture cover 80 has a slot 81 having a shape corresponding to a shape of the holes 32 that are connected to each other, similar to the slots 52 and 56.
  • the suture cover 80 may be omitted.
  • the suture cover 80 is omitted from the drawings.
  • FIG. 10 illustrates this state.
  • a suture L is held by the tips of the needles 26 via the respective slits 26a while the suture L has loosened portions W between the tips of the respective adjacent needles 26 (refer to FIG. 9 ).
  • the suture L extending from the suture bobbin 36 has an end portion La that is located opposite to the suture bobbin 36 with respect to the plurality of needles 26 or stitches N.
  • the end portion La of the suture L is wound around the knot forming jig 66 to form incomplete knots IM. That is, FIG. 10 illustrates a preliminary preparation step.
  • FIG. 11 illustrates this state.
  • the needles 26 start to protrude one after another from the pressing plate 34. That is, FIG. 11 illustrates a sandwiching step.
  • the needle stands 28 are pushed up one after another and located at the second height where the needle stands 28 are on the second positioning surface 40b of the second needle pusher 40.
  • all the needles 26 protrude from the pressing plate 34 by the second protrusion amount h2.
  • the needles 26 penetrate the edges of the cut T and pass through the respective friction holes 56a of the friction plate 54 adhered to the bottom wall 46 of the second casing 14 and the slot 52 of the bottom wall 46 of the second casing 14.
  • FIG. 12 illustrates such a needle penetration step.
  • the needle stands 28 are moved downward one after another and thus located at the first height where the needle stands 28 are on the first positioning surface 38b of the first needle pusher 38. That is, the needles 26 are lowered to be partially retracted below the pressing plate 34 so that the needles 26 protrude from the pressing plate 34 by the first protrusion amount h1.
  • a loop LP is formed at the tip portion 26d of each needle 26 by friction caused between the suture L held by the tip of the needle 26 via the slit 26a and the friction plate 54.
  • FIG. 13 illustrates such a loop forming step.
  • Each loop LP is oriented perpendicular to a plane extending in a direction in which the suture hook 60 is moved forward.
  • FIGS. 14 and 15 illustrate a suture hook insertion step. More specifically, for example, FIG. 14 illustrates a state where the suture hook 60 is being moved forward toward the distal end of the second casing 14 and FIG. 15 illustrates a state where the suture hook 60 has reached the farthest position in the forward movement of the suture hook 60.
  • FIGS. 14 and 15 illustrates the hook 62 oriented extending perpendicular to the bottom wall 46.
  • FIGS. 16, 17 , and 18 illustrate a needle removal step.
  • the suture hook 60 is moved backward while the hook 62 and the butt 64 of the suture hook 62 are oriented extending perpendicular to the bottom wall 46. As illustrated in FIGS.
  • the suture hook 60 is moved backward, the mouth of the hook 62 of the suture hook 60 is closed by the latch 63.
  • the suture hook 60 is moved backward without catching the other loops LP formed at the remaining needles 26.
  • the suture L is drawn from the suture bobbin 36.
  • the suture L has another end portion Lb that is located, in a suturing preparation step, on the same side where the suture bobbin 36 is provided, with respect to the plurality of needles 26 or stitches N.
  • the suture L that has been drawn from the suture bobbin 36 by the suture hook 60 and threaded or is to be threaded through the loops LP may be an end portion Lb of the suture L.
  • a knot M is formed as described below on the end portions La and Lb of the suture L that form stitches N placed in the edges of the cut T by suturing (refer to FIG. 19 ).
  • FIGS. 19 to 25 a description will be provided on a procedure to form the knot M.
  • the components, members or portions other than the edges of the cut T, the suture hook 60, and the knot forming jig 66 may be omitted.
  • the incomplete knots IM have been formed by winding the suture L around the knot forming jig 66 and the suture hook 60. Thereafter, in response to the suture hook 60 being pulled from the incomplete knots IM by its further backward movement in such a state, the state of FIG. 20 shifts to a state of FIG. 21 . In response to the knot forming jig 66 being then pulled from the incomplete knots IM by its backward movement, the state of FIG. 21 shifts to the state of FIG. 22 . Thus, a loose knot M is formed. After that, as illustrated in FIG. 23 , the end portions La and Lb of the suture L are both tightened in a state where the knot forming jig 66 has been moved forward from the state of FIG.
  • FIG. 25 is an enlarged view illustrating an original shape of the knot M.
  • FIG. 26 is an enlarged view illustrating the tightened knot M obtained by tightening the knot M of FIG. 25 .
  • the knot M of FIG. 25 is a square knot.
  • another type of the knot M may be obtained by changing the winding direction of the suture L that forms the incomplete knots IM obtained by winding the end portion La of the suture L around the knot forming jig 66.
  • FIG. 27 is an enlarged view illustrating an original shape of another type of the knot M.
  • FIG. 28 is an enlarged view illustrating the tightened knot M obtained by tightening the knot M of FIG. 27 .
  • the knot M of FIG. 27 is a granny knot.
  • the suturing device 10 includes the first casing 12, the second casing 14, the needles 26, the needle moving mechanism 41, and the suture hook 60.
  • the first casing 12 and the second casing 14 are configured to move toward and away from each other to sandwich therebetween edges of a cut T.
  • the needles 26 are disposed at the first holding member and aligned in the needle arrangement direction with their points pointing to the second casing 14.
  • the needles 26 are configured to hold a suture L at tips thereof and penetrate the edges of the cut T.
  • the needle moving mechanism 41 is configured to move the needles 26 toward the second casing 14, thereby allowing the needles 26 holding the suture L at the respective tips to penetrate the edges of the cut T.
  • the suture hook 60 is disposed at the second casing 14.
  • the suture hook 60 is configured to move along the needle arrangement direction to catch the suture L that has reached the second casing 14 via the edges of the cut T by movement of the needles 26 toward the second casing 14 by the needle moving mechanism 41.
  • the needle moving mechanism 41 moves, toward the second casing 14, the needles 26 that is disposed at the first casing 12 and holds the suture L at their tips.
  • the needles 26 penetrates the edges of the cut T, thereby allowing the tip portions of the needles 26 to reach the second casing 14 via the edges of the cut T.
  • a length of a series of stitches N may be adjusted by changing which of the loops LP formed at the tips of the needles 26 is caught by the suture hook 60.
  • the needles 26 are arranged at equal intervals. Such a needle arrangement may enable stiches N to be placed in edges of a cut T at equal pitches, thereby achieving an appropriate suturing strength.
  • each of the needles 26 has a slit 26a defined in at least the tip portion of the needle 26.
  • the slit 26a is configured to allow the needle 26 to releasably hold the suture L at the tip of the needle 26.
  • the slit 26a extends in the tip portion of each of the needle2 26 along the direction intersecting with the needle arrangement direction, that is, the direction in which the suture hook 60 moves.
  • loops LP may be formed using the suture L held by the tip portions of the respective needles 26 via the respective slits 26a such the loops LP are oriented in a particular direction to allow the suture hook 60 to be readily inserted thereinto, thereby surely suturing edges of a cut T.
  • each of the needles 26 has the acute angled tip and the circumferential wall 26e.
  • the slit 26a extends in at least a particular portion of the circumferential wall 26e along the axial direction of the needle 26 from the point of the acute angled tip to the proximal end of the needle 26 opposite to the acute angled tip in the axial direction of the needle 26.
  • the particular portion of the circumferential wall 26e extends from the point of the acute angled tip of the needle 26.
  • Such a configuration may thus enable each of the needles 26 to have a relatively high holding force for holding the suture L at their tips.
  • the needles 26 may stably hold loops LP formed using the suture L at their tips, thereby securely suturing edges of a cut T.
  • the suturing device 10 includes at least one needle stand 28 supporting the proximal ends of the needles 26 with the points of the needles 26 pointing to the second casing 14.
  • the needle moving mechanism 41 is further configured to move the at least one needle stand 28 toward the second casing 14. With this configuration, in response to the needles 26 being moved toward the second casing 14 by the needle moving mechanism 41, the needles 26 penetrate edges of a cut T sandwiched by the first casing 12 and the second casing 14, thereby allowing the tip portions of the needles 26 to reach the second casing 14 via the edges of the cut T.
  • the at least one needle stand 28 includes a plurality of needle stands 28 each supporting a proximal end of a corresponding needle 26.
  • the needles 26 may be caused by the needle moving mechanism 41 to penetrate edges of a cut T one after another.
  • the first casing 12 includes the needle stand guide 74 configured to guide movement of the needle stands 28 in such a manner to restrict the needle stands 28 from moving in the needle arrangement direction and allow the needle stands 28 to move toward the second casing 14.
  • the needles 26 may be caused by the needle moving mechanism 41 to penetrate edges of a cut T sandwiched by the first casing 12 and the second casing 14 while maintaining the intervals between the needles 26.
  • the needle moving mechanism 41 includes a pusher (e.g., the first needle pusher 38 and the second needle pusher 40) configured to move along the needle arrangement direction.
  • the pusher is further configured to move the needles 26 toward the second casing 14 to protrude from the first casing 12 by engaging the leading end of the pusher with the needle stands 28.
  • the needles 26 may be caused by the pusher to penetrate edges of a cut T sandwiched by the first casing 12 and the second casing 14.
  • the needle moving mechanism 41 includes the first needle pusher 38 and the second needle pusher 40.
  • the first needle pusher 38 is disposed at the first casing 12 and configured to move along the longitudinal axis of the first casing 12.
  • the first needle pusher 38 has the first inclined surface 38a and the first positioning surface 38b.
  • the first inclined surface 38a is configured to, by engaging the needle stands 28 one after another, move the needles 26 toward the second casing 14 to protrude from the first casing 12.
  • the first positioning surface 38b is a flat surface contiguous from the first inclined surface 38a and is configured to position the needle stands 28 at the first height.
  • the second needle pusher 40 is disposed at the first casing 12 and configured to move along the longitudinal axis of the first casing 12.
  • the second needle pusher 40 has the second inclined surface 40a and the second positioning surface 40b.
  • the second inclined surface 40a is configured to, by engaging, one after another, the needle stands 28 that have been moved toward the second casing 14 by the first needle pusher 38, move the needles 26 toward the second casing 14 to further protrude from the first casing 12.
  • the second positioning surface 40b is a flat surface contiguous from the second inclined surface 40a and is configured to position the needle stands 28 at the second height.
  • the needles 26 are moved toward the second casing 14 (e.g., pushed up) to protrude from the first casing 12 by the second protrusion amount h2 via edges of a cut T sandwiched by the first casing 12 and the second casing 14 and then moved toward the first casing 12 (e.g., lowered) to protrude from the first casing 12 by the first protrusion amount h1.
  • Such a needle movement may achieve forming of loops LP at the tips of the respective needles 26.
  • the needle moving mechanism 41 includes the return springs (e.g., the coil springs 78) configured to urge the needle stands 28 toward the first casing 12.
  • the needles 26 penetrating edges of a cut T sandwiched by the first casing 12 and the second casing 14 may be removed therefrom by urging force of the return springs and positioned in the first casing 12.
  • the suturing device 10 includes the knot forming jig 66 disposed at the proximal end portion of the second casing 14.
  • the suture hook 60 is disposed at the proximal end portion of the second casing 14 in such a manner to move along the needle arrangement direction.
  • the knot forming jig 66 has an elongated shape.
  • the end portion La of the suture L is wound around the knot forming jig 66 in advance to form a loop in the suture L for forming a certain knot M.
  • a knot M may be formed by tying an end portion Lb of the suture L and an end portion La of the suture L, thereby stably fastening stiches N placed in edges of a cut T.
  • the end portion Lb may extend from the suture L forming loops LP at the tips of the respective needles 26 and passing through the loops LP together with the suture hook 60.
  • the end portion La of the suture L may be wound around the knot forming jig 66.
  • the knot forming jig 66 is configured to move along the longitudinal axis of the second casing 14. With this configuration, in forming of a knot M, the knot forming jig 66 may be readily pulled out from the loop of the end portion La of the suture L would around the knot forming jig 66.
  • the first casing 12 includes the suture bobbin 36 around which an end portion Lb of the suture L is wound therearound to hold the suture L.
  • the suture bobbin 36 is disposed closer to the distal end of the first casing 12 than the plurality of needles 26 is to the distal end of the first casing.
  • the first casing 12 has an elongated box shape and accommodates the needles 26.
  • the second casing 14 has an elongated box shape and accommodates the suture hook 60.
  • the second casing 14 has friction holes at a position where to hold to hold edges of a cut T.
  • the friction holes 56a allow the needles 26, respectively, to pass therethrough.
  • loops LP may be formed at the tips of the respective needles 26 readily.
  • Other illustrative embodiments of the disclosure will be described below. A description will be provided mainly for the components or elements different from the first illustrative embodiment, and a description will be omitted for the common components or elements by assigning the same reference numerals thereto.
  • FIGS. 29, 30 , and 31 illustrate one example of a second casing 14 according to a second illustrative embodiment.
  • the second casing 14 includes suture hook guides 82 and loop holding members 84.
  • the suture hook guides 82 are configured to guide movement of the suture hook 60 along the needle arrangement direction.
  • the loop holding members 84 are configured to hold respective loops LP held by the tips of the needles 26 in such a manner that the loops LP are oriented extending perpendicular to a plane extending in the needle arrangement direction.
  • either of the suture hook guides 82 and the loop holding members 84 may be omitted or the suture hook guides 82 and the loop holding members 84 may be integral with each other.
  • Each of the suture hook guides 82 has a restriction surface 82a.
  • the set of restriction surfaces 82a and the plurality of needles 26 define a space SF therebetween. More specifically, for example, the space SF is provided between the set of the restriction surfaces 82a and a set of particular surfaces of the circumferential walls 26e of the needles 26. In the circumferential wall 26e of each needle 26, the particular surface is opposite to a surface having the slit 26a.
  • the space SF is configured to receive the suture hook 60 and allow the suture hook 60 to move therein.
  • Each of the loop holding members 84 has a pair of facing surfaces 84a.
  • Each pair of facing surfaces 84a defines a space SL therebetween for receiving a loop LP formed at a tip of a corresponding needle 26.
  • Each space SL is provided on a side of a corresponding needle 26 opposite to a side where the needle 26 has a slit 26a with respect to an axis of the needle 26.
  • the second casing 14 may include a single suture hook guide 82 and a single loop holding member 84.
  • the suture hook guide 82 may have a plurality of restriction surfaces 82a and the loop holding member 84 may have a plurality pairs of facing surfaces 84a.
  • the suture hook 60 is guided through the space SF defined between the set of the restriction surfaces 82a of the suture hook guide 82 and the set of the particular surfaces of the circumferential walls 26e of the needle 26.
  • the particular surface is opposite to a surface having the slit 26a.
  • Loops LP formed at the tips of the needles 26 such that the loops LP are oriented intersecting with the direction in which the suture hook 60 moves, that is, the needle arrangement direction.
  • the loops LP oriented as such are held by the respective loop holding members 84.
  • the suture hook 60 may reliably pass through the loops LP that is held by the tips of the needles 26 and formed on the side opposite to the side where the needle has the slit 26a. Consequently, the suturing device 10 may suture edges of a cut T reliably.
  • FIG. 32 illustrates another example of the second illustrative embodiment.
  • the second casing 14 includes an injection molded combination of the suture hook guides 82 and the loop holding members 84. Such a configuration may thus reduce a parts count of the suturing device 10, thereby achieving a simplified configuration of the suturing device 10.
  • FIG. 33 illustrates another example of the needle moving mechanism 41.
  • a first casing 12 includes a plurality of balloons 86 instead of the first needle pusher 38 and the second needle pusher 40.
  • Each balloon 86 is expandable and disposed between a corresponding needle stand 28 and the bottom wall 24 of the first casing 12.
  • the balloons 86 and the needle stands 28 may function as the needle moving mechanism 41.
  • the balloons 86 are configured to expand by control of fluid pressure to be supplied into the respective balloons 86 to push up the respective corresponding needle stands 28 (e.g., move the respective corresponding needle stands 28 toward the second casing 14).
  • each balloon 86 pushes up a respective corresponding needle stand 28.
  • a single balloon 86 may be configured to push up two or more of the needle stands 28.
  • the suturing device 100 is configured to form a knot M using another procedure after stitches N are placed in edges of a cut T.
  • the suturing device 100 includes a plurality of, for example, two knot forming needles 88 and a plurality of, for example, two needle stands 90 in addition to the needles 26 and the needle stands 28.
  • the knot forming needles 88 and the needle stands 90 may function as a knot forming jig.
  • Each knot forming needle 88 has the same configuration as the needles 26.
  • Each needle stand 90 has the same configuration as the needle stands 28.
  • the knot forming needles 88 and the needle stands 90 on which the knot forming needles 88 stand respectively are disposed next to each other in the needle arrangement direction. That is, the needles 26 and the knot forming needles 88 are aligned in the needle arrangement direction.
  • the knot forming needles 88 do not overlap the cut T, that is, are closer to the proximal end of the first casing 12 than a proximal-side end of the cut T is to the proximal end of the first casing 12.
  • Each knot forming needle 88 has a slit 88a.
  • the suture L is held by the tips of the needles 26 via the slits 26a and by the tips of the knot forming needles 88 via the slits 88a while the suture L has loosened portions W between the tips of the respective adjacent needles 26 and the tips of the knot forming needles 88. As illustrated in FIG. 35 , the suture L is wound one time around each of the knot forming needles 88 to form an incomplete knot IM.
  • FIG. 34 illustrates the suturing device 100 that is opened to increase a distance between the first casing 12 and the second casing 14 and is placed at an appropriate position so that the first casing 12 and the second casing 14 are located on opposite sides of edges of a cut T.
  • FIG. 34 corresponds to the preliminary preparation step of FIG. 10 .
  • FIG. 36 illustrates the suturing device 100 that has been closed to decrease the distance between the first casing 12 and the second casing 14, thereby sandwiching the edges of the cut T between the first casing 12 and the second casing 14.
  • the needles 26 and the knot forming needles 88 protrude from the pressing plate 34 by the second protrusion amount h2 by forward movement of the first needle pusher 38 and the second needle pusher 40 toward the distal end of the first casing 12.
  • the needles 26 penetrate the edges of the cut T and pass through the friction holes 56a of the friction plate 54 disposed on the bottom wall 46 of the second casing 14 and the slot 52 of the bottom wall 46 of the second casing 14.
  • FIG. 36 corresponds to the needle penetration step of FIG. 12 .
  • FIG. 37 illustrates the suturing device 100 in which the second needle pusher 40 has been moved backward toward the proximal end of the second casing 14.
  • the needle stands 28 and 90 are moved downward one after another to be located at the first height where the needle stands 28 and 90 are on the first positioning surface 38b of the first needle pusher 38.
  • the needles 26 and the knot forming needles 88 are partially retracted below the pressing plate 34. Consequently, the needles 26 and the knot forming needles 88 are lowered to protrude from the pressing plate 34 by the first protrusion amount h1.
  • a loop LP is formed at the tip of each of the needles 26 by friction caused between the suture L held by the tip of the needle 26 via the slit 26a and the friction plate 54, and is also formed at the tip of each of the knot forming needles 88 between the suture L held by the tip of the knot forming needle 88 via the slit 88a and the friction plate 54.
  • FIG. 37 corresponds to the loop forming step of FIG. 13 .
  • FIG. 38 illustrates a state after the forward movement of the suture hook 60 is completed.
  • FIG. 38 corresponds to the suture hook insertion step of FIG. 15 .
  • FIG. 39 corresponds to the needle removal step of FIG. 16 .
  • FIG. 40 illustrates the edges of the cut T and the suture L after the needles 26 and the knot forming needles 88 are retracted below the pressing plate 34.
  • Stitches N are formed by the end portion Lb of the suture L and loops Lp. More specifically, for example, the end portion Lb of the suture L extending from the suture bobbin 36 is drawn by the suture hook 60 to pass through each loop LP formed penetrating the edges of the cut T.
  • incomplete knots IM are formed by the end portion Lb of the suture L and loops Lp. More specifically, for example, the end portion Lb of the suture L is drawn by the suture hook 60 to pass through each loop LP formed at the tip of a corresponding knot forming needle 88.
  • FIG. 40 corresponds to FIG. 21 .
  • the knot forming jig 66 functioning as the knot pusher is moved forward toward the distal end of the second casing 14.
  • the end portions La and Lb of the suture L are both tightened, thereby forming a knot M as illustrated in FIG. 41 .
  • the knot M is a square knot illustrated in FIG. 26 .
  • the suturing device 100 of the fourth illustrative embodiment includes the knot forming needles 88.
  • the suture L is wound around each of the knot forming needles 88 for forming a certain knot M and then loops LP are formed at the tips of the knot forming needles 88. Thereafter, the suture hook 60 catching and holding the suture L passes through each loop Lp to form the certain knot M in the suture L held by the suture hook 60.
  • a knot M may be formed by tying an end portion Lb of the suture L and an end portion La of the suture L, thereby stably fastening stiches N placed in edges of a cut T.
  • the end portion Lb may pass through loops LP formed at the tips of the respective needles 26 together with the suture hook 60.
  • the end portion La may extend from a portion of the suture L that forms the loops LP and is wound around the knot forming needles 88.
  • the suture L may be made of any material suitable for ligation.
  • the suture L may be, for example, a natural suture, a synthetic suture, a metallic suture, or a composite suture.
  • the natural suture may be a monofilament or multifilament suture made from plant or animal fibers.
  • the synthetic suture may be a monofilament or multifilament suture made of synthetic fibers.
  • the metallic suture may be a monofilament or multifilament suture made of metallic wires.
  • the composite suture may be made of natural fibers and synthetic fibers.
  • the tubular member 16 has circular shape in cross section. Nevertheless, in other embodiments, for example, a tubular member may have a polygonal shape or an oval shape in cross section instead.
  • first casing 12 and the second casing 14 both have a rectangular shape in cross section.
  • first casing 12 and the second casing 14 may be tubular members each having a circular shape, an oval shape, or a polygonal shape in cross section.
  • the cylindrical drive shaft and the operating rods disposed in the tubular member 16 may be configured to, in one example, be operated manually, or in another example, be operated by an actuator controlled based on a prestored program.
  • a knot M is formed after stitches N are placed in edges of a cut T. Nevertheless, in other embodiments, for example, a knot M might not necessarily be formed after stitches N are placed in edges of a cut T.
  • the needles 26 are provided in a one-to-one correspondence to the needle stands 28. Nevertheless, in other embodiments, for example, a plurality of, for example, two each of the needles 26 may be provided for each of the needle stands 28.
  • each knot forming needle 88 having the same shape as the needles 26 are used. Nevertheless, in other embodiments, for example, each knot forming needle 88 might not necessarily have a sharp point at its tip, that is, may be a rod-shaped needle-like member having a shallow slit 88a or a thready needle-like member.

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EP19796242.6A 2018-05-01 2019-03-22 Suturing device Active EP3777707B1 (en)

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JP2018088471A JP7081287B2 (ja) 2018-05-01 2018-05-01 縫合装置
PCT/JP2019/012032 WO2019211954A1 (ja) 2018-05-01 2019-03-22 縫合装置

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CH662263A5 (de) * 1983-09-13 1987-09-30 Gegauf Fritz Ag Hysterektomium.
JP2006000676A (ja) * 1994-04-14 2006-01-05 Olympus Corp 縫合用糸装着用糸保持具
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US5728112A (en) * 1995-09-22 1998-03-17 Yoon; Inbae Combined tissue clamping and suturing instrument
JPH09299375A (ja) * 1996-05-14 1997-11-25 Manii Kk 医療用糸通し具及び医療用針付糸の保持体
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JP2019193716A (ja) 2019-11-07
CN112040881B (zh) 2024-05-14
US20210045733A1 (en) 2021-02-18
EP3777707A4 (en) 2022-01-12
EP3777707A1 (en) 2021-02-17
WO2019211954A1 (ja) 2019-11-07
CN112040881A (zh) 2020-12-04

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